Module 5 Presentations

05/07/2024

CTR : Triggered Notifications

Topic

CTR

Unexpected event (UE) Within 15 days

Allows the sponsor to inform the MSC about any UE that might materially influence the benefit-risk assessment of the medicinal product, or that would lead to changes in the administration of a medicinal product or in overall conduct of a CT (e.g. a significant hazard to the patient population). Art. 53 of the CT Regulation Allows the sponsor to inform about a breach likely to affect the safety and rights of a subject or the reliability and robustness of the data generated in the CT. Art. 52 of the CT Regulation Allows the sponsor to inform where an unexpected event is likely to seriously affect the benefit-risk balance and the USMs which have been taken to protect the subjects. Art. 54 of the CT Regulation

Serious Breach (SB) Within 7 days

Urgent Safety Measure (USM) Within 7 days

Third country Inspectorate Inspections

Enables the sponsor to submit all inspection reports of third countries authorities concerning a CT. Art. 53 (2) of the CT Regulation

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

37

Managing your changes

CTD

CTR

• New events related to the conduct of a trial or the development of an IMP to affect the safety of subjects

CT-3 paragraph 122

Art. 53.1

EU CTD Art. 10(a) CT-1 s3.7

Chapter III (Art.15 to 24)

• Substantial amendments (planned in advance, ad hoc )

• Additional country submission (CTR)

n/a

Art. 14

Urgent safety measures

EU CTD Art. 10(b), CT-1 s3.9 EU CTD Art. 10(c), CT-1 s4.2.2

•

Art. 54

Early termination of the trial

•

Art. 38

• A temporary halt of a trial for safety reasons i.e. recommendations of the DSMB, if any, where relevant for the safety of subjects,

EU CTD Art. 10(b) for USM, CT-1 s3.10

Art. 38

• Other types of notifications e.g. first patient in, progress reports, etc.

National legislation& local requirements

Art. 37

n/a (except if substantial)

Art 53.2

Inspection reports

•

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

38